NCT03697694

To Assess the Influence of Aronox on Parameters Associated With Aerobic Performance

Completed NA Last updated 6 October 2020

What this trial tests

NA trial testing 500mg of Aronox® >40% polyphenol aronia extract in Aerobic Capacity in 59 participants. Completed in 6 May 2019.

Timeline

4 April 2018

Primary endpoint
15 February 2019

6 May 2019

Quick facts

Lead sponsor	Northumbria University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	59
Start date	4 April 2018
Primary completion	15 February 2019
Estimated completion	6 May 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• 500mg of Aronox® >40% polyphenol aronia extract
• Placebo

Conditions studied

• Aerobic Capacity — all drugs for Aerobic Capacity →

Sponsor

Northumbria University

Who can join

Adults 18 to 50, male only, with Aerobic Capacity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, double blind, counterbalanced, placebo controlled independent groups design. Participants will then be familiarized with the ergometer to determine settings and seating position and randomized to an investigational product group (2 groups: Aronox vs placebo; 1:1 allocation). A time to undergo baseline testing will then be scheduled (day 0). On the baseline day, stature, body mass, blood pressure and heart rate will be assessed. Participants will then complete a submaximal aerobic performance test (lactate profile) where expired gas, heart rate, blood lactate,and RPE will be measured. Following a 10-min rest, participants will then perform a ramp test to exhaustion to determine VO2max (this will be to finalize eligibility to the study - VO2max of 45-70 ml/kg/min). Expired gas, heart rate, power output, perceived exertion, and near-infra-red spectroscopy will be collected throughout and blood lactate will be determined at test termination. Those that do not fulfill the criteria for VO2max will be excluded from the study at this point. Those that are eligible (verified by their VO2max) will consume a standardized 'light' meal and rest for 2 h. Time to exhaustion (TTE) trial (60%GET) determined from previous tests (lactate profile and VO2max) will then be completed. On completion of the TTE trial, the first dose of the investigational product will be administered in the laboratory and participants will be given a 4-week supply of the investigational product to take in the morning with breakfast. Participants will also be given study diaries to complete (exercise, general health, dietary intake). On the final study day (day 28), remaining investigational capsules and study diaries will be collected to monitor compliance. An identical trial to day 0 will then be conducted, following which participants will be asked if they knew what supplement they were asked to consume and be given the chance to provide feedback on their experience.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.